EP4406496A1 - Elektrodenballonkatheter - Google Patents

Elektrodenballonkatheter Download PDF

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Publication number
EP4406496A1
EP4406496A1 EP22886030.0A EP22886030A EP4406496A1 EP 4406496 A1 EP4406496 A1 EP 4406496A1 EP 22886030 A EP22886030 A EP 22886030A EP 4406496 A1 EP4406496 A1 EP 4406496A1
Authority
EP
European Patent Office
Prior art keywords
balloon
electrode
catheter according
electrodes
inflated
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22886030.0A
Other languages
English (en)
French (fr)
Inventor
Xiaofei JI
Zhaohua Chang
Bin YUE
Yingzhong YAO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Microport Rotapace Medtech Co Ltd
Original Assignee
Shanghai Microport Rotapace Medtech Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Microport Rotapace Medtech Co Ltd filed Critical Shanghai Microport Rotapace Medtech Co Ltd
Publication of EP4406496A1 publication Critical patent/EP4406496A1/de
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/22022—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement using electric discharge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement applying a shock wave
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising

Definitions

  • the present invention relates to the field of medical devices and, in particular, to an electrode balloon catheter.
  • PCI percutaneous coronary intervention
  • a calcified lesion is often treated by dilation with a balloon. This, however, tends to cause balloon-induced barotrauma, which may lead to intimal disruption, thrombosis, vascular restenosis and other issues.
  • Shockwave balloon catheters based on the electrohydraulic effect can crush fibrotic and calcified plaques in blood vessels, effecting rapid disruption and dilatation of calcified lesions.
  • a shockwave balloon catheter works by generating high-voltage pulsed electric fields each lasting for a short period of time ( ⁇ 10 ms) within a blood vessel, creating high-pressure sound waves.
  • shockwave balloon catheters In most existing shockwave balloon catheters, electrodes are arranged on the catheter body and therefore far away from the exterior of the balloon body. However, the energy density of shock waves diminishes exponentially as a function of the distance they propagate. Therefore, the large spacing would greatly reduce the effectiveness of shock waves for diseased tissue, requiring extending the duration of the surgical procedure and increasing cycles of release from the electrodes. Consequently, ischemic complications tend to occur due to dilatation of the blood vessel and occlusion of blood flow for a prolonged period of time. Moreover, the increased number of shockwave release cycles imposes more stringent requirements on the service life of the electrodes, eventually affecting the material and size of the electrodes and the crossability of the catheter, and increasing the cost of fabrication.
  • shockwave balloon catheters based on the electrohydraulic effect have been found with deficiencies, in particular a large distance from the shockwave source to the target lesion and poor performance in targeted treatment of asymmetrically calcified lesions.
  • the present invention provides an electrode balloon catheter that allows for the adjustment of the position of the electrodes so as to adjust a propagation distance for shock waves. This allows more efficient lesion treatment, reduced surgical duration and an extended service life of the electrodes. Moreover, it has the advantages of a simple structure and ease of surgical operation.
  • the electrode balloon catheter comprises:
  • At least one electrode pair may be disposed on an outer surface of the inner balloon.
  • the electrode pair may comprise a positive electrode and a negative electrode, wherein the positive electrode and the negative electrode are insulated from each other, and wherein an insulating distance between the positive electrode and the negative electrode is fixed or variable.
  • the insulating distance between the positive and negative electrodes may be configured within a predetermined range.
  • the predetermined range may be from 0.01 mm to 10 mm.
  • the electrode pair may comprise a positive electrode and a negative electrode, wherein the positive electrode and the negative electrode are insulated from each other, and wherein the positive electrode and the negative electrode are rigidly connected, flexibly connected or not connected.
  • the electrode pair may comprise two electrodes with opposite polarities, wherein each electrode is formed on the surface of the inner balloon by electroplating or is provided in the form of a flexible circuit.
  • the electrode balloon catheter may comprise a plurality of electrode pairs, wherein the plurality of electrode pairs are arranged axially along and circumferentially around the inflated inner balloon.
  • each of the electrode pairs may comprise a positive electrode and a negative electrode, wherein the positive electrode and the negative electrode of each electrode pair are arranged axially along the inflated inner balloon, wherein the positive and negative electrodes in adjacent electrode pairs are connected by electrical leads.
  • the inner balloon may be made of a compliant material or a non-compliant material.
  • the catheter body may comprise an inner tube and an outer tube, the inner tube received in the outer tube and protruding out of a distal end of the outer tube, wherein: each of a proximal end and a distal end of the inner balloon is fixedly attached to the inner tube; a proximal end of the outer balloon is fixedly attached to the outer tube; a distal end of the outer balloon is fixedly attached to the inner tube; an outer-balloon fluid supply lumen in communication with the outer balloon is formed between the inner and outer tubes; and an inner-balloon fluid supply lumen in communication with the inner balloon is provided within the inner tube.
  • the catheter body may further comprise a handle that is located at a proximal end, wherein the proximal end of the inner and the proximal end of outer tube are connected to the handle, the handle provided with an outer-balloon fluid inlet and an inner-balloon fluid inlet, the outer-balloon fluid inlet connected to the outer-balloon fluid supply lumen, the inner-balloon fluid inlet connected to the inner-balloon fluid supply lumen.
  • a handle that is located at a proximal end, wherein the proximal end of the inner and the proximal end of outer tube are connected to the handle, the handle provided with an outer-balloon fluid inlet and an inner-balloon fluid inlet, the outer-balloon fluid inlet connected to the outer-balloon fluid supply lumen, the inner-balloon fluid inlet connected to the inner-balloon fluid supply lumen.
  • an inflated outer balloon may have a diameter of 0.75 mm to 30.0 mm and an axial length of 3 mm to 300 mm.
  • an inflated inner balloon may have a diameter of 0.5 mm to 29.0 mm and an axial length of 3 mm to 300 mm.
  • the electrode balloon catheter in the electrode balloon catheter as defined above, through positioning the electrode pairs on the inner balloon, their positions relative to a target lesion can be adjusted by inflating or deflating the inner balloon, thereby changing a propagation distance for shock waves and their impingement energy on the target lesion. This can enhance lesion treatment efficiency, reduce the surgical duration and extend the service life of the electrodes. Moreover, in the electrode balloon catheter, adjustability in position of the electrode pairs through manipulating the balloon can be achieved by a simple structure and can provide ease of surgical operation.
  • the electrode balloon catheter as defined above, if the electrode pairs are provided on the outer surface of the inner balloon, the electrodes can come into direct contact with the conductive medium, imparting greater directionality to the propagation of shock waves. As a result, shock waves can more effectively radiate outwardly towards the outer surface of the outer balloon, resulting in an increase in lesion treatment efficiency. Otherwise, if the electrodes are disposed on the inner surface of the inner balloon, they can be protected by both balloons and is therefore safer.
  • the positive and negative electrodes in each electrode pair may be insulated from each other at a fixed or variable insulating distance, adding more flexibility to lesion treatment.
  • the insulating distance will vary as a result of inflating the inner balloon. This allows the intensity of energy released from pulsed electric fields to be adjusted in a flexible manner and results in higher lesion treatment efficiency.
  • the electrode can be directly formed on the surface of the inner balloon by electroplating, enabling easier assembly of the electrodes.
  • the electrodes can have a reduced thickness, which allows the catheter to have a smaller outer diameter during crossing.
  • the electrodes may be provided in the form of flexible circuits. In this case, the electrodes will be more flexible and easier to fold and also allow a smaller outer diameter during crossing.
  • a plurality of electrode pairs may be incorporated, which are arranged both axially along and circumferentially around the inflated inner balloon.
  • the electrode pairs are preferred to be connected in series by electrical leads.
  • the positive and negative electrodes in each electrode pairs may be arranged axially along the inflated inner balloon, and positive and negative electrodes in adjacent electrode pairs may be connected by electrical leads.
  • a catheter body 11, an inner tube; 111, an outer-balloon fluid supply lumen; 112, an inner-balloon fluid supply lumen; 12, an outer tube; 2, an outer balloon; 22, a tapered section; 21, a straight section; 3, an inner balloon; 4, an electrode pair; 5, an electrical lead; 6, a handle; 61, an outer-balloon fluid inlet; 62, an inner-balloon fluid inlet; and 63, an energy interface.
  • connection and derivatives thereof may be used to refer to a direct connection between systems, components, or elements, or to a connection established by a medium intervening between systems, components, or elements, i.e., an indirect connection.
  • first and second herein is not meant to be limiting of the numerical number of the referenced item and is only intended to distinguish one component from another.
  • proximal end and distal end are employed to describe relative orientations, relative positions and directions between components of an electrode balloon catheter according to the present invention or actions thereof, as viewed by a surgeon using the device.
  • Proximal end is usually used to describe an end farther away from a patient and closer to an operator, in contrast to “distal end” being usually used to describe an end closer to the patient and farther away from the operator, during normal operation of the electrode balloon catheter, although these terms are not intended to be limited to being used in such a way.
  • axial”, “radial” and “circumferentially” may be used herein to describe directions parallel to, perpendicular to and about an axis, respectively.
  • plurality is defined herein as two or more than two.
  • Electrode balloon catheters proposed in embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
  • the present invention provides an electrode balloon catheter including a catheter body 1, an outer balloon 2, an inner balloon 3 and electrode pairs 4. Both the outer balloon 2 and the inner balloon 3 are provided at an end of the catheter body 1.
  • the inner balloon 3 is disposed inside the outer balloon 2 and configured to attach the electrode pairs 4 thereto.
  • the interior of the outer balloon 2, which is defined as a space between the outer balloon 2 and the inner balloon 3, is configured to store a conductive medium for transmitting shock waves.
  • At least one of the electrode pairs 4 is disposed on the inner balloon 3, e.g., on its inner or outer surface. When the electrode pairs 4 are disposed on the outer surface of the inner balloon 3, they can come into direct contact with the conductive medium, imparting greater directionality to the transmission of shock waves. As a result, shock waves can more effectively radiate outwardly towards an outer surface of the outer balloon 2. Otherwise, if the electrode pairs 4 are disposed on the inner surface of the inner balloon 3, they can be protected by both balloons and is therefore safer.
  • a plurality of electrode pairs 4 are provided, in which some may be provided on the inner surface of the inner balloon 3, and the remaining one(s) may be provided on outer surface of the inner balloon 3. Alternatively, all the electrode pairs 4 may be provided on the inner surface of the inner balloon 3, or on the outer surface thereof.
  • the electrode pairs 4 are configured to accept high-voltage pulses for generating shock waves, and each electrode pair 4 includes one positive electrode and one negative electrode, which are insulated from each other at an insulating distance configured within a predetermined range.
  • each electrode pair 4 is configured to generate pulsed electric fields between the positive and negative electrodes in the form of positive and negative electrode signals. If the insulating distance between the electrodes is not large enough, sparking may occur, or cold plasma may be generated.
  • the insulating distance between the two electrodes is designed within the predetermined range, which can ensure sufficient energy strength of the generated electric fields while not causing ionization. In this way, it can be ensured that desired energy can be delivered to a target lesion at a safe level.
  • the insulating distance refers to a distance between the positive and negative electrodes in a deflated or inflated configuration of the inner balloon 3, which varies in the course of deflation or inflation of the inner balloon 3 while always remaining within the predetermined range.
  • Use of the electrode balloon catheter of the present invention may involve inflating the outer balloon 2 so that it expands and fits onto a target calcified lesion in a blood vessel in a patient while surrounding the inner balloon 3 and the electrode pairs 4 to prevent the electrodes from coming into direct contact with tissue of the patient.
  • the electrode pairs 4 can be adjusted in position with respect to the target lesion by modifying a degree of inflation, and hence a diameter, of the inner balloon 3. In this way, a propagation distance for shock waves, and hence a level of energy of shock waves acting on the target lesion, may be modified, making the device suitable for use in more therapeutic treatment applications.
  • the electrode pairs 4 will be brought closer to the target lesion, reducing the propagation distance for shock waves.
  • the outer balloon 2 is shown as being in an inflated configuration, and the inner balloon 3 in a non-inflated configuration.
  • the outer balloon 2 when fully inflated, can fit against and dilate the target lesion, and the electrode pairs 4 on the surface of the inner balloon 3 are distant from the outer balloon 2 in the collapsed configuration of the inner balloon 3.
  • shock waves released from the electrode pairs 4 will propagate through the conductive medium in the outer balloon 2 to the outer balloon 2 and the wall of the blood vessel surrounding the outer balloon 2 and impinge on the calcified lesion.
  • the shock waves have to propagate a large distance, the energy density of them acting on the calcified lesion is relatively low.
  • both the outer balloon 2 and the inner balloon 3 are shown as being in an inflated configuration.
  • the electrode pairs 4 on the surface of the inner balloon 3 will be brought closer to the surface of the outer balloon 2, as well as to the diseased tissue.
  • the distance from the electrode pairs 4 to the surface of the outer balloon 2 is reduced, i.e., the propagation distance for shock waves.
  • the inner balloon 3 may be inflated to a degree determined as required by the treatment of the lesion.
  • the inner balloon 3 may be either fully inflated to a maximum diameter, or to a smaller diameter.
  • the outer balloon 2 is usually fully inflated so that it can fit against the blood vessel and dilate the vessel.
  • the electrodes in the electrode balloon catheter of the present invention is made freely movable within the outer balloon 2. This results in improved performance in crushing a calcified lesion, reduced surgical duration, a lower risk of causing ischemic complications, a reduced number of required cycles of shockwave release and an extended service life of the electrodes.
  • the electrode pairs 4 in the electrode balloon catheter of the present invention may be arranged on the surface of the inner balloon into alignment with the asymmetric lesion and then brought closer to the lesion as a result of inflating the inner balloon. In this way, targeted treatment of the asymmetrically calcified lesion can be achieved.
  • the inner and outer balloons are typically folded during delivery. That is, both the inner balloon 3 and the outer balloon 2 are folded and crimped on the catheter body 1.
  • the electrodes on the inner balloon 3 may be folded with the inner balloon 3.
  • the electrodes may be provided, for example, in the form of very small patches or flexible circuits.
  • the folded balloons allow a small outer diameter during crossing.
  • the flexible circuits may be small, lightweight, thin, soft and flexible.
  • the number and arrangement of the electrode pairs 4 may be determined as required, as long as shock waves released from the electrodes can propagate to a target lesion in a blood vessel in a desired manner and achieve a desired therapeutic result.
  • a plurality of electrode pairs 4 are provided on the inner balloon 3, which are arranged axially along and/or circumferentially around the inner balloon 3.
  • the number and positions of electrode pairs 4 that are circumferentially arranged determine a circumferential (or angular) impingement range of shock waves for a calcified lesion, and the number and positions of electrode pairs 4 that are axially arranged determine an axial (or lengthwise) impingement range of shock waves for a calcified lesion.
  • Figs.l to 6 9 electrode pairs are shown, which are arranged both axially along and circumferentially around the inner balloon 3. It is a matter of course that the positive and negative electrodes in each electrode pair 4 are insulated from each other.
  • the positive and negative electrodes in each electrode pair 4 may be insulated from each other at an insulating distance within a predetermined range, which is preferred to be 0.01 mm to 10 mm and more preferred to be 0.1 mm to 2.0 mm.
  • electrode pairs 4 are shown, which are arranged both axially along and circumferentially around the inner balloon 3.
  • the number of electrode pairs 4 is not limit to 6 or 9 as exemplified above.
  • the plurality of electrode pairs 4 may be axially arranged either uniformly or not. Likewise, they may be circumferentially arranged either uniformly or not.
  • the positive and negative electrodes in each electrode pair 4 are insulated from each other at a fixed insulating distance in order to ensure that consistent energy is released in each cycle. Accordingly, despite the variable propagation distance, shock waves with constant energy will be released from each electrode pair 4, and the insulating distance remains the same even when the inner balloon 3 vary in shape or size.
  • the positive and negative electrodes in each electrode pair 4 may be rigidly connected to each other and then fixed to the inner balloon 3 as a whole.
  • by “rigidly connected” it is intended to mean that when one of the positive and negative electrodes is displaced or stressed, the other electrode connected thereto will not displace or deform with respect to the first electrode.
  • the positive and negative electrodes in each electrode pair 4 are insulated from each other at a variable insulating distance, which allows the intensity of energy delivered to be modified and adds flexibility to lesion treatment. Accordingly, as the propagation distance varies, the energy of shock waves released from each electrode pair 4 will change, e.g., increase or decrease, and the insulating distance will change in response to shape or size changes of the inner balloon 3. The degree of inflation, and hence the diameter, of the inner balloon 3 may be controlled to ensure that the variable insulating distance remains within the predetermined range. In order to achieve such a variable insulating distance, the positive and negative electrodes in each electrode pair 4 may be flexibly connected together and then fixed to the inner balloon 3 as a whole.
  • the positive and negative electrodes in the electrode pairs 4 may be individually fixed to the inner balloon 3 without being connected together. As a result, the positive and negative electrodes can move freely and independently during inflation of the inner balloon 3.
  • the fixation may be accomplished by adhesive bonding, welding or electroplating.
  • the electrodes are directly formed on the surface of the inner balloon 3 by electroplating, or made in the form of flexible circuits and attached to the inner balloon 3.
  • fabricating the electrodes by electroplating allows the electrodes to have a smaller thickness and allows the electrode balloon catheter to have a reduced outer diameter during crossing.
  • Providing the electrodes in the form of flexible circuits can facilitate their folding and also allows the electrode balloon catheter to have a reduced outer diameter during crossing.
  • the electrode pairs 4 may be connected to electrical leads 5.
  • the positive electrodes in the electrode pairs 4 may be connected to a positive terminal of a power supply of a high-voltage pulse generator via electrical leads 5
  • the negative electrodes in the electrode pairs 4 may be connected to a negative terminal of the power supply of the high-voltage pulse generator via electrical leads 5.
  • the high-voltage pulse generator is configured to provide pulses required by the electrode pairs 4 for generating shock waves.
  • the high-voltage pulse generator may control the frequency and number of cycles of shockwave release from the electrodes by turning on and turning off a circuit.
  • a “ring electrode” may be shape like a ring that can be fitted over the inner balloon 3, and a “patch electrode” may be in the shape of a substantially flat or slightly curved patch that can be attached to the inner balloon 3.
  • the electrodes are patch electrodes designed based on the principles of point discharge, which can provide high energy density and enhance the electrohydraulic effect.
  • the application is not limited to any particular arrangement of the electrode pairs 4 on the inner balloon 3. They may be individually independent of one another, or connected in series or parallel.
  • Fig. 7 six electrode pairs 4 are shown as being connected in series, as an illustrative example.
  • the six electrode pairs 4 are arranged both axially along and circumferentially around the inflated inner balloon 3. For example, they may be arranged into two circumferential rows and three axial columns.
  • the six electrode pairs 4 may be connected in series by electrical leads 5. More specifically, the negative electrode (labeled as "-" in Fig. 7 ) in each electrode pair 4 may be connected to the positive electrode (labeled as "+" in Fig. 7 ) in an adjacent electrode pair 4 via an electrical lead 5.
  • a series circuit may be formed with a positive terminal connected to the positive terminal of the power supply of the high-voltage pulse generator and with a negative terminal connected to the negative terminal of the power supply of the high-voltage pulse generator.
  • Fig. 7 shows the inner balloon 3 that has been inflated and then "unrolled". As can be seen in the unrolled plan view of the inflated inner balloon 3, the six electrode pairs 4 are connected in series by electrical leads 5, and the positive and negative terminals of the resulting series circuit are connected to the high-voltage pulse generator via electrical leads 5. This arrangement allows fewer electrical leads 5 to be used to connect the electrode pairs 4 and the high-voltage pulse generator. As a result, the catheter is allowed to have a reduced overall size and a smaller outer diameter during crossing.
  • the six electrode pairs 4 may be connected in parallel using electrical leads 5.
  • the positive electrode in each electrode pair 4 may be connected to the positive electrode in an adjacent electrode pair 4 via an electrical lead 5
  • the negative electrode in each electrode pair 4 may be connected to the negative electrode in an adjacent electrode pair 4 via an electrical lead 5.
  • a parallel circuit may be formed with a positive terminal connected to the positive terminal of the power supply of the high-voltage pulse generator and with a negative terminal connected to the negative terminal of the power supply of the high-voltage pulse generator.
  • the electrode pairs 4 may not be mutually connected by electrical leads 5. Instead, they may be independent of one another and separately connected to the high-voltage pulse generator.
  • the positive electrode in each electrode pair 4 may be connected to the positive terminal of the power supply of the high-voltage pulse generator via an electrical lead 5
  • the negative electrode in each electrode pair 4 may be connected to the negative terminal of the power supply of the high-voltage pulse generator via an electrical lead 5.
  • This application is not limited to any particular material of the outer balloon 2. It may be made of a compliant or non-compliant material, preferably of a compliant material, because it can impart good crush resistance to the outer balloon 2 and enables it to better dilate a blood vessel. Moreover, it allows the balloon to be folded to an even smaller size, making it easier for the balloon to pass through, and hence dilate and treat, a narrow calcified lesion.
  • a compliant material suitable for making the outer balloon 2 may be selected from polyurethane (PU), polyethylene (PE), silicone and other materials.
  • a non-compliant material suitable for making the outer balloon 2 may be selected from polyethylene terephthalate (PET), nylon and other materials.
  • Figs. 2 and 5 show the outer balloon 2 in an inflated configuration.
  • the outer balloon 2 may comprise a straight section 21 and tapered sections 22 joined to the straight section 21 at its opposite ends.
  • the balloon dilates a blood vessel essentially by the straight section 21. Therefore, the straight section 21 can be considered as an effective section of the balloon.
  • the outer balloon 2 when inflated, may have a diameter and axial length determined according to the size and extent of a target lesion to be treated.
  • the outer balloon 2 when inflated may have a diameter in the range of 0.75 mm to 30.0 mm, preferably 2.0 mm to 20 mm, and an axial length in the range of 3 mm to 300 mm, preferably 4 mm to 250 mm.
  • this application is not limited to any particular material of the inner balloon 3. It may be made of a compliant or non-compliant material.
  • the inner balloon 3 may be made of the same compliant material as that of the outer balloon 2, which may be selected from, for example, PU, PE, silicone and other materials.
  • the inner balloon 3 may be made of the same non-compliant material as that of the outer balloon 2, which may be selected from, for example, PET, nylon and other materials.
  • the insulating distance can be considered as constant.
  • the material of the inner balloon 3 is selected as a compliant material, if the two electrodes in each electrode pair 4 are flexibly connected, then relatively large displacement may occur between them, leading to a change in their insulating distance.
  • the insulating distance between the two electrodes in each electrode pair 4 can be considered as constant, no matter whether they are rigidly connected, flexibly connected or not connected.
  • the material of the inner balloon 3 is compliant, in order to achieve a constant insulating distance between the 2 electrodes in each electrode pair 4, these electrodes must be rigidly connected to each other.
  • the inner balloon 3, when inflated, may have a diameter and axial length determined according to the size and extent of a target lesion to be treated.
  • the inner balloon 3, when inflated may have a diameter ranging from 0.5 mm to 29.0 mm, preferably from 0.7 mm to 28.0 mm, and an axial length ranging from 3 mm to 300 mm, preferably from 6 mm to 180 mm.
  • the diameter of the inflated outer balloon 2 is greater than that of the inflated inner balloon 3.
  • the axial length of the inflated outer balloon 2 is greater than that of the inflated inner balloon 3.
  • the insulating distance between the positive and negative electrodes in each electrode pair 4 is 0.7 mm.
  • the inner balloon 3 is allowed to be inflated to a maximum diameter of 2.5 mm, and the outer balloon 2 is allowed to be inflated to a maximum diameter of 3.0 mm.
  • the catheter body 1 may comprise an outer-balloon fluid supply lumen 111 and an inner-balloon fluid supply lumen 112, as shown in Fig. 2 .
  • the outer-balloon fluid supply lumen 111 may communicate with the outer balloon 2 to allow a fluid (e.g., the conductive medium) to be supplied to the outer balloon 2 via the fluid supply lumen 111 to inflate the outer balloon 2.
  • fluid evacuation can be achieved through the outer-balloon fluid supply lumen 111 to deflate the outer balloon 2.
  • the inner-balloon fluid supply lumen 112 may communicate with the inner balloon 3 to allow a fluid to be supplied to the inner balloon 3 via the fluid supply lumen 112 to inflate the inner balloon 3.
  • fluid evacuation can be achieved through the inner-balloon fluid supply lumen 112 to deflate the inner balloon 3.
  • the catheter body 1 may include an inner tube 11 and an outer tube 12.
  • the inner tube 11 may be inserted in the outer tube 12, with its distal end extending out of the outer tube 12.
  • a proximal end of the outer balloon 2 may be fixedly attached to the outer tube 12.
  • distal end of the outer balloon may be fixedly attached to the inner tube 11.
  • the inner balloon 3 may be fixedly attached at both its proximal and distal ends to the inner tube 11.
  • the outer-balloon fluid supply lumen 111 may be disposed between the inner tube 11 and the outer tube 12, and the inner-balloon fluid supply lumen 112 may be arranged within the inner tube 11.
  • the inner tube 11 may comprise either one or a plurality of lumens.
  • the catheter body 1 may further include a proximal handle 6, to which both the inner tube 11 and the outer tube 12 may be proximally connected.
  • the handle 6 may be provided with an outer-balloon fluid inlet 61 and an inner-balloon fluid inlet 62.
  • the outer-balloon fluid inlet 61 may connect the outer-balloon fluid supply lumen 111, and the inner-balloon fluid inlet 62 may connect the inner-balloon fluid supply lumen 112. Both the outer-balloon fluid inlet 61 and the inner-balloon fluid inlet 62 may be connected to external fluid sources.
  • the handle 6 may include an energy interface 63, and the electrical leads 5 may be connected to the high-voltage pulse generator through the energy interface 63.
  • radiopaque structures may be provided at the distal end of the inner tube 11 and within the inner balloon 3.
  • one radiopaque ring may be provided at each of the proximal and distal ends of the inner balloon to allow locate the inner and outer balloons through X-ray radiography.
  • the electrode balloon catheter may further include the high-voltage pulse generator, which may be disposed at the proximal end of the catheter body 1.
  • the electrode pairs 4 may generate electrical arcs which vaporize the surrounding conductive medium to form vapor bubbles. These vapor bubbles will expand and eventually burst, generating shock waves which propagate through the conductive medium within the outer balloon 2 to the outer balloon 2 and the wall of the blood vessel surrounding the outer balloon 2 and impinge upon a target calcified lesion. Repeated such pulses can crush the calcified lesion while not causing damage to the vessel wall or surrounding soft tissue.
  • the conductive medium can be used to inflate and expand the outer balloon 2.
  • the conductive medium may be a physiological saline solution, conductive hydrogel, conductive antioxidant fluid, contrast fluid or the like.
  • the conductive antioxidant fluid is non-invasive to the electrodes and can enhance durability of the electrodes.
  • the conductive medium may be filled into the outer balloon 2. This allows delivery of the outer balloon 2 prior to the inflation in a configuration with a smaller outer diameter and hence enhanced crossability. This configuration may be attained by expelling air from the outer balloon 2 and thus causing its collapse over the exterior of the catheter.
  • the electrode balloon catheter is advanced through a stenotic lesion by virtue of its small outer diameter to a target lesion (i.e., a calcified region).
  • a target lesion i.e., a calcified region.
  • an amount of a conductive medium is filled into the outer balloon 2 through the outer-balloon fluid supply lumen 111 in communication with the outer balloon 2.
  • the amount and pressure of the filled conductive medium are controlled so that the outer balloon 2 is inflated to a diameter at which the outer balloon 2 completely fits onto the target lesion.
  • the conductive medium is radiopaque to X-rays, allowing an operator to observe inflation of the outer balloon 2 and its adherence to the target lesion through X-ray radiography.
  • a volume of a fluid is filled into the inner balloon 3 through the inner-balloon fluid supply lumen 112 in communication with the inner balloon 3.
  • the fluid is a contrast agent.
  • the volume of the filled fluid is controlled so that the inner balloon 3 is inflated to a diameter at which the electrode pairs 4 thereon are located at desired positions.
  • the high-voltage pulse generator generates high-voltage pulses, which are then transmitted to the electrode pairs 4 through the electrical leads 5.
  • high-energy electrons build up on the electrodes and eventually break down the conductive medium between the electrodes in the electrode pairs 4, generating shock waves by the electrohydraulic effect.
  • the electrode balloon catheter can pre-dilate the stenotic lesion and ensure a sufficiently large vascular lumen, allowing subsequent access of a medical device with a relatively large outer diameter to the target lesion, such as a stent delivery device, drug-coated balloon, or the like.
  • the inventive electrode balloon catheter allows adjustability of a distance from the electrodes to target diseased tissue through manipulating the inner balloon. This can reduce energy loss of shock waves during propagation, enhance the performance in crushing a calcified lesion, reduce the surgical duration and cycles of shockwave release, extend the service life of the electrodes and lower the risk of complications.
  • the adjustability of the distance from the electrodes to the target diseased tissue is accomplished by changing a degree of inflation of the inner balloon. This results in higher lesion treatment efficiency and enables the targeted treatment of an asymmetric, eccentric calcified lesion, making the electrode balloon catheter suitable for use in more therapeutic treatment applications and more powerful in therapeutic treatment.
  • the electrode balloon catheter of the present invention is particularly suited to use in interventional treatment of coronary artery disease. Of course, it can also be used in interventional treatment of other blood vessel diseases.

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EP22886030.0A 2021-10-27 2022-10-26 Elektrodenballonkatheter Pending EP4406496A1 (de)

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CN202111257836.6A CN113842190A (zh) 2021-10-27 2021-10-27 电极球囊导管
PCT/CN2022/127730 WO2023072154A1 (zh) 2021-10-27 2022-10-26 电极球囊导管

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EP4265203A4 (de) * 2020-12-16 2024-10-16 Sonosemi Medical Co Ltd Druckwellenballonkatheter und medizinische vorrichtung
CN113842190A (zh) * 2021-10-27 2021-12-28 上海微创旋律医疗科技有限公司 电极球囊导管
CN114903558B (zh) * 2022-05-19 2023-11-10 杭州天路医疗器械有限公司 一种用于体内腔道塑形的冲击波发生装置
CN114831697B (zh) * 2022-05-19 2024-03-19 杭州天路医疗器械有限公司 一种用于体内腔道塑形的冲击波发生装置
CN115153753B (zh) * 2022-08-05 2023-01-24 谱创医疗科技(上海)有限公司 一种自适应柔性电极球囊装置
CN115553869A (zh) * 2022-11-15 2023-01-03 南京沃福曼医疗科技有限公司 一种环状放电电极对阵列及球囊导管
CN115624367B (zh) * 2022-11-18 2023-03-10 乐普（北京）医疗器械股份有限公司 一种治疗血管钙化的辅助装置
CN115778487A (zh) * 2023-02-02 2023-03-14 上海佳沐垚医疗科技有限公司 一种可用于靶向治疗的冲击波球囊导管及导管系统

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CN104736073A (zh) * 2012-08-06 2015-06-24 冲击波医疗公司 冲击波导管
JP6204483B2 (ja) * 2012-11-02 2017-09-27 べシックス・バスキュラー・インコーポレイテッド バルーンアセンブリ
CN108452426A (zh) * 2018-03-16 2018-08-28 上海心至医疗科技有限公司 一种基于液电效应的球囊导管
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CN214907695U (zh) * 2020-12-16 2021-11-30 深圳市赛禾医疗技术有限公司 一种压力波球囊导管及医疗器械
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CN113842190A (zh) * 2021-10-27 2021-12-28 上海微创旋律医疗科技有限公司 电极球囊导管

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